Eli Lilly lymphoma drug fails, charge to R&D $30 million
Phase III clinical trial was a part of PRELUDE study, which explored the molecule as a monotherapy in the prevention of relapse in patients with diffuse large B-cell lymphoma (DLBCL).
The study failed to show a statistically significant increase compared to placebo in disease-free survival in patients at high risk of relapse following rituximab-based chemotherapy. The safety data were consistent with previously disclosed studies.
Lilly will stop development of enzastaurin, which is expected to result in a second-quarter charge to R&D expense of approximately $30 million. The company's previously-issued financial guidance for 2013 remains unchanged.
"We are disappointed in the results that we're announcing today. However, our oncology pipeline is still one of the most robust across the industry containing more than 20 molecules, including two Phase III molecules in five different tumor types," said Richard Gaynor, vice president of product development and medical affairs for Lilly Oncology.
Patients enrolled in PRELUDE had histologically confirmed DLBCL with an International Prognostic Index (IPI) score of three to five at diagnosis. The IPI is a simple, clinical tool that is used to predict survival outcomes for patients with DLBCL. ■